Percutaneous stimulation device and method for detecting compartment syndrome

ABSTRACT

A diagnosis device, and more particularly, a compartment syndrome diagnostic device is described herein. The diagnostic device may include a display that renders information associated with stimulation of a motor unit suspected of suffering from compartment syndrome. The diagnostic device may generate a stimulation signal for stimulating the motor unit through an electrode. The device may determine whether the motor unit is at risk for compartment syndrome based on the response of the motor unit to the stimulation. The diagnostic device may also measure pressure of a compartment. The device may determine whether the motor unit is at risk for compartment syndrome based on the measured pressure and the response of the motor unit to the stimulation.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.16/594,322 filed on Oct. 7, 2019 and entitled “PERCUTANEOUS STIMULATIONDEVICE AND METHOD FOR DETECTING COMPARTMENT SYNDROME” which is acontinuation of U.S. patent application Ser. No. 14/704,690 filed May 5,2015 and entitled “PERCUTANEOUS STIMULATION DEVICE AND METHOD FORDETECTING COMPARTMENT SYNDROME,” now U.S. Pat. No. 10,433,785, whichclaims the benefit of U.S. Provisional Patent Application Ser. No.61/988,665, filed May 5, 2014, and entitled “PERCUTANEOUS STIMULATIONDEVICE AND METHOD FOR DETECTING COMPARTMENT SYNDROME,” each of which areincorporated herein by reference in their entirety.

FIELD OF USE

This invention relates to a device and a method for detectingcompartment syndrome.

BACKGROUND OF THE INVENTION

Compartment syndrome is a common condition where a traumatic or crushinginjury causes muscle swelling, raising the tissue pressure in one of thebody's compartments, such as an arm, leg or other enclosed space withinthe body. The increased tissue pressure begins a cycle in which thecirculation is impaired, leading to higher pressures, which furtherdecrease circulation, perpetuating the cycle. If the cycle is nottreated by a fasciotomy (in which a large incision is used to relievepressure in the extremity), it can lead to muscle death and catastrophicloss of function.

The fascia envelope that surrounds muscle and bone is strong andrelatively inelastic. Because of the strength and inelasticity of thefascia envelope, the pressure inside the compartment may significantlyincrease with even a small amount of bleeding into the compartment orwith swelling of the muscles within the compartment. Common causes ofcompartment syndrome include tibial or forearm fractures, ischemicreperfusion following injury, hemorrhage, vascular puncture, intravenousdrug injection, casts, prolonged limb compression, crush injuries andburns.

The clinical signs of compartment syndrome are the 5 “Ps”: pain (out ofproportion to the injury), paresthesias (numbness), paralysis (loss ofmuscle contractility), pallor (loss of pulses), tense skin and vascularcongestion. Poikilothermia (loss of normal thermoregulation) can also bea symptom of compartment syndrome. The clinical presentation may beambiguous and these signs cannot be assessed in an obtunded orunconscious patient.

Because the clinical signs can be confusing or ambiguous, particularlyin early stages, compartment pressures are usually measured in order toconfirm the diagnosis. Markedly elevated pressures are clearlyindicative of compartment syndrome. Typically, the normal pressureinside the compartment is in the range of about 5-10 mm Hg. In caseswhere the compartment pressure increases to 50-60 mm Hg, there willalmost certainly be tissue necrosis within the compartment due to lackof new blood perfusion. In this case, compartment release surgery (e.g.,a fasciotomy) is necessary to avoid muscle death and potentialcatastrophic loss of function to the injured limb. This surgery involvesa large incision to relieve the pressure in the injured limb and can bedisfiguring. In some cases, a skin graft is required to close theincision. In addition, severe complications, including post-surgicalinfections, can occur. However, the risks associated with thesecomplications are less severe than the complications associated withcompartment syndrome.

There is some ambiguity and even disagreement as to what constitutes adangerous compartment pressure reading. Some advocate a relativecriterion in which the pressure is within 30 mm Hg of the diastolicblood pressure. Others recommend an absolute pressure but again there issome disagreement over whether that number should be in the high 20 mmHg range or whether it should be higher in the mid-30 mm Hg range.

If the pressures clearly exceed the threshold, then a fasciotomy shouldbe performed, but the challenge is whether to perform the fasciotomywhen the pressure is just below the threshold (e.g., 20-25 mm Hg) andthe patient only exhibits some (but not all) of the clinical signs (e.g.pain with passive extension, weakness, paralysis, or numbness). If thepressure measurement is repeated some time (e.g., 1 hour) later with nochange in results, then the patient may be considered at borderline riskof compartment syndrome. Presently, the risks of compartment syndromefar outweigh the risks of fasciotomy. This leads to fasciotomies beingperformed that probably would not be necessary if there were a morereliable test. Fasciotomies can be disfiguring (i.e., long incisionsrequiring skin grafts to close) and accompanied by severe complications(e.g., infection), but the complications of fasciotomies are less severethan the complications of compartment syndrome. With more accurateinformation from stimulation, it may be possible to protect the at riskmuscle by performing an endoscopic or minimally invasive fasciotomywithout the need for a large incision.

SUMMARY OF THE INVENTION

Embodiments described herein relate to devices, systems or methods fordiagnosing or detecting compartment syndrome and monitoring for severityof compartment syndrome. It is an object of this invention to provide amore reliable device and method for detecting compartment syndrome.

In an embodiment, a device may be configured for generating a stimulussignal suitable for eliciting muscle contraction of a motor unit of acompartment; and monitoring at least one stimulation parameterassociated with a stimulation threshold of a motor unit of thecompartment. The device may further be configured for generating arendering of a representation of data describing a history of the atleast one stimulation parameter.

In another aspect, compartment syndrome diagnosis device, comprising: astimulation component configured to generate a stimulation signal; aprobe operatively in communication with a motor unit suspected ofcompartment syndrome, wherein the stimulation component is furtherconfigured to stimulate the motor unit via the probe and based on thestimulation signal; an intermuscular pressure sensing componentconfigured to measure a pressure of a compartment comprising the motorunit; and a display device configured to render a display indicatingstimulation parameters associated with stimulation and pressureparameters.

Described herein is a method for diagnosing compartment syndrome,comprising: stimulating, via a device comprising a processor, a motorunit in a compartment suspected to be at risk of compartment syndrome;determining a stimulation threshold associated with activation of themotor unit; and monitoring at least one of a history of stimulationthresholds over a period of time or a history of interstitial pressureover a period of time.

BRIEF DESCRIPTION OF THE DRAWINGS

Operation of the invention may be better understood by reference to thefollowing detailed description taken in connection with the followingillustrations, wherein:

FIG. 1 is a diagnostic system for detecting compartment syndromeaccording to embodiments disclosed herein;

FIG. 2 is a functional block diagram of a diagnostic system fordetecting compartment syndrome according to embodiments disclosedherein;

FIG. 3 is a functional block diagram of a diagnostic system fordetecting compartment syndrome including a printer component accordingto embodiments disclosed herein;

FIG. 4 is a functional block diagram of a diagnostic system fordetecting compartment syndrome including a motion sensor componentaccording to embodiments disclosed herein;

FIG. 5 is multi-channel diagnostic system for detecting compartmentsyndrome including pressure sensors according to embodiments disclosedherein;

FIG. 6 is multi-channel diagnostic system for detecting compartmentsyndrome according to embodiments disclosed herein;

FIG. 7 is a percutaneous lead for a diagnostic system according toembodiments disclosed herein;

FIG. 8 is a percutaneous lead for a diagnostic system with returnelectrode and a connection to a stimulator according to embodimentsdisclosed herein;

FIG. 9 is a method for determining a stimulus threshold according toembodiments disclosed herein;

FIG. 10 is a method for diagnosing compartment syndrome according toembodiments disclosed herein;

FIG. 11 is an environmental diagram of an exemplary communication systemaccording to embodiments disclosed herein; and

FIG. 12 is a block diagram of a functional computer system according toembodiments disclosed herein.

DETAILED DESCRIPTION

Reference will now be made in detail to exemplary embodiments of thepresent invention, examples of which are illustrated in the accompanyingdrawings. It is to be understood that other embodiments may be utilizedand structural and functional changes may be made without departing fromthe respective scope of the invention. Moreover, features of the variousembodiments may be combined or altered without departing from the scopeof the invention. As such, the following description is presented by wayof illustration only and should not limit in any way the variousalternatives and modifications that may be made to the illustratedembodiments and still be within the spirit and scope of the invention.

As used herein, the words “example” and “exemplary” mean an instance, orillustration. The words “example” or “exemplary” do not indicate a keyor preferred aspect or embodiment. The word “or” is intended to beinclusive rather an exclusive, unless context suggests otherwise. As anexample, the phrase “A employs B or C,” includes any inclusivepermutation (e.g., A employs B; A employs C; or A employs both B and C).As another matter, the articles “a” and “an” are generally intended tomean “one or more” unless context suggest otherwise.

Furthermore, the terms “patient,” “subject,” and the like are employedinterchangeably throughout the subject specification, unless contextsuggests otherwise or warrants a particular distinction among the terms.It is noted that such terms may refer to an animal, such as a human,dog, horse, or the like. Likewise, terms such as “target tissue” and“motor unit” may be used interchangeably throughout, unless contextsuggests otherwise. Such terms may include muscle tissue, nerve tissue,muscle and nerve tissue, or the like. Moreover, examples describingstimulation of “muscle tissue” may also refer to stimulation of “nervetissue,” or a combination of both (and vice versa). It is noted,however, that such examples may list less than all possible motor unitsfor sake of brevity.

Moreover, terms such as “doctor,” “physician,” “clinical worker,” andthe like are employed interchangeably throughout the subjectspecification, unless context suggests otherwise or warrants aparticular distinction among the terms. Such terms may refer to anentity that may interact with a device and a patient, performprocedures, performs methods disclosed herein, and the like. Further,while embodiments and examples may describe a clinical worker or patientperforming certain tasks, it is noted that a machine may perform tasks,such as through automation, logic, processors, and the like.

“Logic” refers to any information and/or data that may be applied todirect the operation of a processor. Logic may be formed frominstruction signals stored in a memory (e.g., a non-transitory memory).Software is one example of logic. In another aspect, logic may includehardware, alone or in combination with software. For instance, logic mayinclude digital and/or analog hardware circuits, such as hardwarecircuits comprising logical gates (e.g., AND, OR, XOR, NAND, NOR, andother logical operations). Furthermore, logic may be programmed and/orinclude aspects of various devices and is not limited to a singledevice.

Moreover, terms such as “access point,” “server,” “network device,” andthe likes, are utilized interchangeably, and refer to a networkcomponent or appliance that sends and receives data, data-streams, orsignaling-streams. Data and signaling streams may be packetized orframe-based flows. A network typically includes a plurality of elementsthat host logic. In packet-based wide-area networks (WAN), servers(e.g., devices comprising logic) may be placed at different points onthe network. Servers may communicate with other devices and/ordatabases.

Embodiments may utilize substantially any wired or wireless network. Forinstance, embodiments may utilize various radio access network (RAN),e.g., Wi-Fi, global system for mobile communications, universal mobiletelecommunications systems, worldwide interoperability for microwaveaccess, enhanced general packet radio service, third generationpartnership project long term evolution (3G LTE), fourth generation longterm evolution (4G LTE), third generation partnership project 2,BLUETOOTH®, ultra mobile broadband, high speed packet access, x^(th)generation long term evolution, or another IEEE 802.XX technology.Furthermore, embodiments may utilize wired communications.

Aspects of systems, apparatuses or processes described herein relate toa diagnostic system for detecting medical conditions of a user. Inparticular, the diagnostic system may provide for or assist in detectionof compartment syndrome. The diagnostic system may include a stimulationcomponent that may monitor stimulation parameters associated withstimulation of tissue (e.g., muscle, nerve tissue, and/or both). Thestimulation parameter may include a stimulation recruitment threshold,such as a stimulation intensity at which a motor unit begins to fire(e.g., muscle twitch). The stimulation component may monitor changes instimulation parameters based on a history of the stimulation parameters.

In embodiments, the stimulation component may include a single generatorthat generates a stimulation signal. A single generator may be coupledto an electrode. The electrode may deliver the stimulation signal to atissue region, such as to stimulate or attempt to stimulate the tissue.In another aspect, the electrode may be implanted on or near the tissue,on a surface above the tissue, or the like. For instance, the electrodemay be disposed on a probe (e.g., needle and/or catheter), apercutaneous coiled fine wire lead, or the like.

A clinical worker, user, and/or a device (e.g., of the diagnosticsystem, of a separate system) may monitor tissue response to astimulation signal. The tissue response may be entered into or receivedby the stimulation component.

In another aspect, the diagnostic system may include or communicate witha pressure component. The pressure component may measure a pressure in atissue region, such as a compartment. The diagnostic system may generatealarms based on measured pressure, stimulation thresholds, or acombination thereof.

In an example, a patient may suffer a crushing or compacting injury totheir arm (or other body part). The patient may experience one or moresymptoms associated with compartment syndrome, such as out of proportionpain, paresthesias (numbness), paralysis (loss of muscle contractility),pallor (loss of pulses), tense skin and vascular congestion, andpoikilothermia (loss of normal thermoregulation). Such symptoms may ormay not be results of compartment syndrome. If compartment syndrome isleft untreated, the patient may lose use of their arm or even requireamputation of their arm. Accordingly, the patient may visit a medicalfacility for diagnosis.

A clinical worker or doctor may assess the injury and may utilizediagnostic systems and methods described herein to assist in diagnosis.For instance, the doctor may attach (e.g., implant) electrodes in alocation to stimulate muscle and/or nerves (e.g., motor units in thecompartment). To stimulate the tissue, the doctor may utilize a probecoupled to the diagnostic system. The doctor may set an intensity forstimulation through an interface of the diagnostic system. The doctormay then observe the tissue to determine a result of the stimulation(e.g., muscle response, no response, intensity of response, etc.). Basedon the result, the doctor may adjust the intensity until a stimulationrecruitment threshold is reached. The doctor may repeat the process fordetermining stimulation recruitment thresholds at various intervals. Thediagnostic system may monitor the stimulation recruitment thresholds andpresent information to the doctor regarding a history of the stimulationrecruitment thresholds (e.g., increase/decrease in intensity ofstimulation, etc.).

It is an object of this invention to provide a more reliable device andmethod for detecting compartment syndrome. One aspect of the inventionprovides a percutaneous stimulation device for detecting compartmentsyndrome comprising a percutaneous intermuscular (IM) lead, anintroducing needle and a portable stimulator with a skin mounted returnelectrode. The percutaneous IM lead is operatively connected to theportable stimulator. The system allows measuring the threshold ofstimulation for muscle contractility.

In one aspect of the invention, the percutaneous stimulation devicegenerates a single pulse every one to two seconds and records stimulusintensity that results in a visible or palpable muscle contraction(twitch). In another aspect of the invention, the percutaneousstimulation device produces a pattern of stimulation and wherein thepattern of stimulation comprises a burst of 2-4 pulses at 16 Hzrepeating every 1 or 1.5 seconds. The percutaneous stimulation devicemay include a percutaneous combination of a pressure sensingcatheter/sensor with a stimulating electrode, an introducing needle, anda portable stimulator. The stimulating electrode with the pressuresensing catheter may be capable of delivering electrical stimulation andmonitoring intracompartmental pressure.

In another aspect of the invention, a method for detecting compartmentsyndrome is disclosed. The method comprises inserting a percutaneouslead into a muscle in a compartment of a patient suspected of having ordeveloping compartment syndrome; establishing a threshold of stimulationintensity for visible or palpable muscle contraction; monitoring thethreshold of stimulation intensity over time; and determining whether anincrease in the threshold of stimulation intensity is indicative of alikelihood of developing or advancing severity of compartment syndrome.

In another aspect of the invention, in addition to establishing andmonitoring the threshold of stimulation intensity, compartment pressuremeasurements may be taken. Assessment of the likelihood of compartmentsyndrome may include both the changes over time of the stimulationintensity threshold and the compartment pressure measurements. Thethreshold of stimulation intensity may be determined by a portablestimulator. Monitoring the threshold of stimulation intensity may bedetermined by monitoring the presence or absence of visible or palpablemuscle contractions. The percutaneous stimulation device may alsoinclude the IM electrode or a second electrode.

Referring now to FIG. 1 , there depicted is a diagnostic system 100.Diagnostic system 100 may be used to diagnose a patient, and inparticular to indicate whether a patient has compartment syndrome andthe severity of the compartment syndrome. Diagnostic system 100 mayprovide an altered level (e.g., improved level) of sensitivity andspecificity in comparison with other diagnostic systems or methods. Suchdiagnostic systems or methods typically rely on measuring pressure withthe compartment.

Pressure is an imperfect surrogate for what is really of concern as aresult of compartment system, namely whether there is alteration ofmuscle metabolism, mitochondrial death or decreased circulation leadingto muscle necrosis. Hence, contractility of the muscle in thecompartment, which is of direct concern, may provide a different (e.g.,improved) measure than pressure. Correct diagnosis is not academic sincethe treatment involves a decompressive fasciotomy which involves a longincision, a risk of wound infection and subsequent surgical proceduresto close the wound, which could even necessitate the use of a skingraft, creating a second area of significant scar.

Diagnostic system 100 may include a body 110 comprising variouscomponents (e.g., power source, memory, processor, etc.) and circuitry.The body 110 may be connected (removably or irremovably) to astimulation interface 130 comprising a signal path (e.g., wire, etc.)136 coupled (removably or irremovably) to a probe 132 and a pressuresensor 134. It is noted that diagnostic system 100 may comprise other ordifferent components not shown for sake of brevity. It is further notedthat diagnostic system 100 may be comprised within larger systems.

The body 110 may include a display 124 and controls 126. In an example,the display 124 may include a monitor, touch screen monitor, or thelike. Further, controls 126 may include input devices and/or may becomprised by the display 124. For instance, controls 126 may includebuttons (pressure sensitive buttons, mechanical buttons, rocker buttons,etc.), dials, slideable controls, switches, keypads, keyboards, or thelike.

In embodiments, diagnostic system 100 may be a handheld system. In ahandheld system, the body 110 may include an internal power source(e.g., battery) or may be coupled with an external power source. Aninternal power source may include a battery. The battery may berechargeable, such as through a power mains, universal serial bus (USB)port, power adaptor, wireless charger (e.g., near field communicationcharging, etc.), or the like. Further, body 110 may comprise anergonomic design, including grips, bumpers, textured surfaces, or thelikes. Such ergonomic designs may allow for increased patient and doctorsatisfaction. In an aspect, diagnostic system 100 may include straps,clips, or other attachment components for attaching or securing thediagnostic system 100 to an object. For instance, a patient may utilizea clip to secure body 110 to a bed, stand, or other structure. Inanother example, the body 110 may be clipped, strapped, or otherwiseattached to a patient or patient's clothing. By attaching to thepatient, the patient may wear the body 110 for monitoring while allowingthe patient to move or rest. In another aspect, body 110 may compriselightweight materials suitable for handheld or wearable use. Forinstance, body 110 may comprise plastic or other material, lightweightpower supplies, and the like.

Probe 132 may include a stimulation probe, needle, catheter,percutaneous stimulation lead, or other components suitable fordelivering a stimulation signal. In one aspect, probe 132 may include aneedle adapted to attach to a stimulation probe to allow forpercutaneous stimulation. The probe 132 may be inserted on or near to atarget motor unit (e.g., area of suspected compartment syndrome). Inanother aspect, the probe 132 may be at least partially disposable orreusable. For instance, a needle attachment may be designed for a singleuse while a stimulation probe may be designed for reusable applications.As such, probe 120 may comprise various different designs orconfigurations.

In an example, probe 132 may comprise a percutaneous (or needle)stimulation probe that may be inserted into a compartment or muscle atan injury site to assess the chance that compartment syndrome willdevelop and/or has developed. Diagnostic system 100 may provide astimulation signal and the threshold of stimulation intensity forvisible muscle contraction may be established by stimulation of themuscle, (e.g., through the probe 132) on the involved side or bystimulation of the contralateral compartment or muscle (e.g., samecompartment/muscle on the opposite side) to establish baseline thresholdand then monitoring over time (e.g., a couple of hours). In this way,the patient may serve as his/her own control. Changes in the thresholdintensity (or presence/absence of a muscle contraction) could indicatechanges in the compartment pressure. An increase in threshold mayindicate the situation is getting worse and fasciotomy may be needed,and a decrease in threshold may indicate that a fasciotomy may not beneeded.

In another example, probe 132 may include a percutaneous intermuscular(IM) lead that is placed into a target muscle near a major motor pointwith, for example, a hypodermic introducing needle. The percutaneous IMlead may be a coiled, threaded, braided fine wire, and the like. In anaspect, the percutaneous IM lead may be left or implanted into themuscle for repeated use. During a monitoring process, the percutaneousIM lead may be secured to the skin with, for example, an adhesive suchas tape. At the end of the monitoring process, the percutaneous IM leadmay be removed and discarded.

In an exemplary embodiment, diagnostic system 100 may generate anelectrical stimulation signal. The stimulation signal flows from thediagnostic system 100 through a lead 136 to probe 132. The stimulationsignal then flows through a predefined insulated path within the probe132 and to an operative element, such as an electrically conductivesurface, e.g., an electrode. The electrode is to be positioned in amuscle in a compartment of a patient to be stimulated. In monopolaroperation, a return electrode (or indifferent electrode) provides anelectrical path from the body back to the control device. Thestimulation control device may operate in a monopolar or bipolarconfiguration.

The return electrode (e.g., a surface electrode) may be a skin-mountedelectrode. The system is used to identify and record one or twothresholds of stimulation; e.g., the threshold of just palpablestimulation and a higher threshold such as visible joint motion. Thepattern of stimulation employed may be a single pulse or burst of pulses(e.g., 2-4 pulses at 16 Hz repeating every 1 or 1.5 seconds). Thestimulation and manual observation of the muscle response may beperformed at time intervals, such as every i minutes, where i is anumber (e.g., 5, 15, 30, or 45 minutes, etc.).

While embodiments describe diagnostic system 100 as measuring thethreshold of stimulation, it is noted that diagnostic system 100 mayinclude or communicate (directly or indirectly) with other systems thatmay measure the threshold of stimulation. Such other systems may, forexample, provide stimulation to a motor unit and may communicateparameters of the stimulation (e.g., intensity, frequency, etc.) to thediagnostic system 100. For example, diagnostic system 100 may include orcommunicate with a stimulation device. The stimulation device maystimulate a motor unit suspected of having compartment syndrome. Adoctor may adjust the intensity of stimulation to determine a thresholdof stimulation. In an embodiment, the diagnostic system 100 may receivemeasurements and/or stimulation parameters from the stimulation device,such as through a communication network (e.g., wireless, wired, etc.)and/or through manual input. For instance, the diagnostic system 100 mayreceive input from a doctor. The doctor may determine values of theinput based on settings or output from the stimulation device.

The configuration of the stimulation device may vary in form andfunction. Various representative embodiments of illustrative stimulationdevices are described and depicted in U.S. Publication No. 2013/0296733,which is hereby incorporated in its entirety.

The stimulation device is adapted to provide an indication or status ofthe device. The indication may include a physical motor response (e.g.,twitching), and/or one or more visual or audio signals from thestimulation control device, which indicate to the surgeon the status ofthe device, and/or close proximity of the electrode to a nerve, or amuscle, or a nerve and a muscle. The stimulation control device may alsoindicate to the surgeon that the stimulation control device is operatingproperly and delivering a stimulus current.

In an aspect, the diagnostic system 100 may include a processor ormicrocontroller that may operate at a low voltage and low power. Themicrocontroller may send a low voltage pulse to a stimulus output stagethat converts these low voltage signals into the higher voltage,controlled voltage, or controlled current, stimulus pulses that areapplied to the electrode circuit. This stimulus output stage usuallyinvolves the use of a series capacitor to prevent the presence of DCcurrent flow in the electrode circuit in normal operation or in theevent of an electronic component failure.

In addition to generating the stimulus bursts, the diagnostic system 100may report the stimulus intensity. This intensity may be recorded fordata trending by the diagnostic system 100. Alternatively, the intensitymay be recorded by a clinician observing the stimulus or by any otherappropriate recording means. The diagnostic system 100 may alert a userwhen it is time for the next point of monitoring. The diagnostic system100 may also be programmed to provide a plot of the monitoring overtime, such as through display 124 and/or a display in communication withdiagnostic system 100, and may be wirelessly connected to a display suchas a display of a desktop computer. For example, the diagnostic system100 may be connected (e.g., wirelessly or via a wire line) to a displayor computing device (e.g., tablet computer, etc.).

The diagnostic system 100 could be used in a situation in which apatient comes into the emergency department following trauma that maylead to compartment syndrome. A percutaneous lead (e.g., probe 132) maybe inserted into a muscle in the compartment at risk of compartmentsyndrome.

In at least one embodiment, diagnostic system 100 may include apercutaneous combination of a thin fluid-filled catheter with astimulating electrode that may both 1) deliver the electricalstimulation and 2) monitor the intracompartmental pressure. In anotheraspect, pressure sensor 134 may be an implantable pressure sensor thatmay be implanted with an electrode. In such an example, diagnosticsystem 100 may not require the fluid-filled catheter. It is noted that,while diagnostic system 100 may be described as comprising a probe 132for stimulation and a pressure sensor 134, the probe 132 and/or pressuresensor 134 may be separate systems or devices. In such instances,diagnostic system 100 may communicate (e.g., via a communicationnetwork, via user interaction, etc.) with the stimulation device and/orpressure sensing device. It is further noted that the probe 132 forstimulation and the pressure sensor 134 may be comprised by onecomponent (e.g., such as a catheter).

Where only the intracompartmental pressure is monitored, the diagnosticsystem 100 may automatically qualify and record the pressure for a giventime interval (e.g., every minute) and present the data as a plot of thepressure over time. One advantage of this approach is to create amonitoring record without the need for a qualified clinician/nurse to bepresent at each monitoring event.

Turning to FIG. 2 , there is a functional block diagram of diagnosticsystem 200. According to at least one embodiment, diagnostic system 200may measure the threshold of stimulation (e.g., stimulation recruitmentthreshold) for muscle contractility. In another aspect, the threshold ofstimulation may be measured when the pressure in the compartment isinconclusive as to whether there is a risk for the development ofcompartment syndrome. Diagnostic system 200 may reduce the incidence ofunnecessary surgery, including fasciotomies.

Diagnostic system 200 may primarily include compartment syndrome system206, memory 202, and processor 204. Memory 202 may be configured forstoring computer executable components such as a stimulation component210, an interface component 240, and an input component 230. Processor204 may facilitate operation of the computer executable components. Itis noted that system 200 may include one or more devices, such as anexternal pressure sensor device, an external stimulation device, and thelike. It is further noted that one or more devices may comprise, atleast in part, the various components. For instance, a single componentof system 200 may be comprised by one or more devices. Further, whileshown as separate or distinct components, the components of system 200may be comprised by one or more components. It is noted that system 200may include a plurality of compartment syndrome systems 206 that may belinked together through a network and transceivers. These compartmentsyndrome systems may be operatively linked with a server that mayoperate or otherwise communicate with the compartment syndrome systems.

It is noted that diagnostic system 100 of FIG. 1 may comprise all orpart of system 200. For example, compartment syndrome system 206 may becomprised within body 110. In another aspect, compartment syndromesystem 206 may generate output 212 as a stimulation signal and mayreceive input 214 as a response from a clinician or another system.

In embodiments, stimulation component 210 may control a stimulationdevice as described herein. For instance, stimulation component 210 maycontrol parameters for stimulation, such as signal intensity, signalfrequency, and the like. In an aspect, the frequency for stimulation maybe within a range of frequencies that produce easily observed (e.g., bya physician and/or device) motor responses (e.g., muscle twitch). In anaspect, the range may have a lower bounds (e.g., such as about 0.5 hertz(HZ)) and an upper bounds (e.g., about 50 HZ). In another aspect, therange may be between about 0.7 HZ to about 3 HZ. It is noted that thefrequency range may vary depending on desired configurations, subjects,and the like.

According to at least one embodiment, stimulation component 210 maycontrol stimulation of a plurality of motor units. For instance,stimulation component 210 may be coupled with a plurality of electrodesthat may each be in electrical contact with a disparate compartment. Forexample, a patient may come to a hospital after being in a serious caraccident. The patient may suffer multiple injuries to differentcompartments and the different compartments may be monitored or checkedfor compartment syndrome via system 200. For instance, a doctor mayconnect electrodes (e.g., via percutaneous implants, probes, etc.) totarget tissue regions in the compartments. The doctor may selectstimulation parameters for the different compartments and system 200 mayapply the parameters to the compartments via the electrodes.

Interface component 240 may communicate or control input/output devices(e.g., monitors, speakers, light emitting diode (LED) indicators,touchscreens, human interface devices, mouse, keyboard, keypad, nobs,controls, etc.) network devices, and the like. In an example, interfacecomponent 240 may receive input 214 as an input from a doctor, such asvia controls 126. The doctor may provide input to configure or alterstimulation parameters, such as stimulation intensity. As describedherein, the doctor may adjust the stimulation intensity to determine athreshold stimulation.

It is noted that the threshold stimulation values may be measured ordetermined at various times. In an aspect, the diagnostic system 100 maymonitor and/or store a history of the threshold stimulation values. Forinstance, a doctor may check the threshold of stimulation at varioustimes and/or in response to triggering events.

Triggering events may include time intervals (e.g., every 5, 15, 30, 45minutes, etc.), change in pressure (e.g., increase/decrease in pressure,rate of change, etc.), change in patient's symptoms, or the like. Inembodiments, interface component 240 may control an interface togenerate an alert or notification indicative of a request to check athreshold of stimulation. For instance, the interface may include amonitor, a LED, a speaker, a vibration device, or the like. As such, thenotification may include a visual, audible, and/or tactile notification.For instance, system 200 may generate a rendering of an image (e.g.,still or moving) or text on a display (e.g., display 124), adjusting adisplay parameter (e.g., brightness, etc.), control a LED statusindicator, generate an audible notification (e.g., voice, chime, melody,etc.); generate a vibration, or the like. It is noted that thenotification may be sent to another device, such as through email,telephone networks (e.g., wired or wireless, text messages, voicemessages, data messages, etc.), over intranet connections, over internetconnections, or the like. In an example, system 200 may initiate a callto a nurse station. When the clinical work answers the call, aprerecorded or predetermined message may be played, or the like.

Referring now to FIG. 3 with reference to FIGS. 1-2 , depicted is asystem 300 that may monitor stimulation and pressure associated withmotor units in a compartment. It is noted that like named components ofsystem 300 and other embodiments may include substantially similarfunctionality. For instance, stimulation component 310 may includefunctionality similar to stimulation component 210. Diagnostic system300 may primarily include compartment syndrome system 306, memory 302,and processor 304. Memory 302 may be configured for storing computerexecutable components such as a stimulation component 310, a printercomponent 320, an interface component 340, a pressure component 350, andan input component 330. Processor 304 may facilitate operation of thecomputer executable components. It is noted that system 300 may comprisedifferent components and may comprise one or more devices.

In an aspect, printer component 320 may control a remote printer or aprinter internal to system 300, such as a printer comprised by system100. In embodiments, a remote printer may include a printer connected tosystem 300 via a communication network (wireless or wired), directlyconnected (wirelessly or wired), or the like. In embodiments, printercomponent 320 may instruct the printer to print data associated withstimulation, a patient, a doctor, or the like. For instance, the printercomponent 320 may instruct a printer to print a graphical representationof stimulation thresholds and pressure measurements.

Pressure component 350 may measure or receive measurements associatedwith pressure in a compartment of a patient. For instance, a pressurecomponent 350 may communicate with a pressure-reading device. Thepressure-reading device may be comprised within system 100, for example.In another aspect, the pressure-reading device may be an externalsystem. The pressure reading device may comprise a catheter orneedle-based device (as described herein, an ultra sonic device, e.g.,transmitter, etc., or other pressure sensing devices. In embodiments,the pressure-reading device and/or a doctor may provide input 314regarding a determined pressure.

Stimulation component 310 and/or pressure component 350 may determinetrends in the pressure of a compartment and/or response thresholds ofmotor units within the compartment. In an aspect, interface component340 may instruct a display to render the trends. The rendering mayinclude graphical representations, textual representations, and/oraudible representations. For example, the pressure and stimulationthresholds may be rendered as plots or graphs as seen in FIG. 1 . A plotmay show data over a fixed period of time and/or it may scale a timeaxis to display all available data. It is noted that pressure andstimulation threshold may be represented in a single graph and/or inmultiple graphs.

In various embodiments, input component 330 may receive input 314 from adoctor or other user. The input may be related to requests for renderingdata associated with pressure and/or stimulation. For instance, a doctormay provide input to indicate a preference for representing historicalinformation associated with the pressure and/or stimulation (e.g.,timeline values, color, plot type, etc.). The preferences may be stored(e.g., in memory 202) for later use.

In another aspect, system 300 (e.g., via interface component 340) maygenerate alarms or indicators based on information associated withpressure and/or stimulation. For example, the alarm may be based on apressure level exceeding a threshold pressure level, a rate of pressureincrease exceeding a threshold rate, stimulation threshold exceeding astimulation intensity threshold, a rate of stimulation thresholdintensity exceeding a threshold rate, a weighted combination of variousfactors exceeding a threshold, or the like. In various examples,thresholds may be predetermined, set by a doctor, or dynamicallydetermined. For instance, baseline values may be determined, such as bymeasurements of non-compartment syndrome areas of a patient. Thebaseline may then be used to dynamically determine thresholds. In anexample, systems described herein may provide a stimulation signal andthe threshold of stimulation intensity for visible muscle contractionmay be established by stimulation of the muscle, (e.g., through theprobe 132) on the involved side or by stimulation of the contralateralmuscle (same muscle on the opposite side) to establish baselinethreshold and then monitoring over time (e.g., a couple of hours).Likewise, pressure may be determined on the contralateral compartment.In this way, the patient may serve to generate his or her ownthresholds.

As described above, system 300 may generate various alarms or alerts. Inresponse to the alarms, the doctor may recheck pressure, stimulationthresholds, make a diagnosis, and the like.

FIG. 4 is a system 400 that may monitor stimulation and pressureassociated with motor units in a compartment. It is noted that likenamed components of system 400 and other embodiments may includesubstantially similar functionality. For instance, stimulation component410 may include functionality similar to stimulation component 210and/or 310. Diagnostic system 400 may primarily include compartmentsyndrome system 406, memory 402, and processor 404. Memory 402 may beconfigured for storing computer executable components such as astimulation component 410, a printer component 420, an interfacecomponent 440, a pressure component 450, motion sensor component 460,and an input component 430. Processor 404 may facilitate operation ofthe computer executable components. It is noted that system 400 maycomprise different components and may comprise one or more devices.

Motion sensor component 460 may include or control motion sensordevices, such as a muscle twitch sensor. The muscle twitch sensor may beattached to a body part associated with stimulation. The muscle twitchsensor may be attached, such as via a strap or an adhesive (e.g., tape),directly to a patient's skin and/or clothing. This sensor may comprise astrain sensor, motion sensor, and the like (e.g., an accelerometer). Inan example, stimulation component 410 may periodically (or upon atriggering event) generate a stimulation signal (e.g., output 412) andmay titrate the magnitude of that stimulation. Motion sensor component460 may determine when motion of a muscle twitches. Stimulationcomponent 410, based on the muscle twitch detection, may determine thethreshold of nerve/muscle stimulation. In an aspect, this may allowfully automatic generation of the trend plot of pressure and stimulusthreshold over time and any subsequent alarm generation. It is notedthat a motion sensor may be disposable or reusable. It is noted that themotion sensory component 460 may utilize or comprise other devices orsystems to determine a muscle twitch, such as an electromyography (EMG)electrode. An EMG electrode may use small surface electrodes or apercutaneous coiled fine wire lead (disposable and supplied sterile) todetermine muscle twitch. In at least one embodiment the EMG electrodemay be the same electrode delivering a stimulation signal. In anotheraspect, system 400 may differentiate between a stimulation signal and anelectrical signal generated by volitional movement of the muscle. Forinstance, the system may distinguish between the signals based on adelay due to muscle response, a frequency of the signals, an intensityof the signals, or the like.

In an aspect, motion sensor component 460 may be configured todifferentiate between muscle twitches caused by the simulation component410 and other movements (e.g., movements cause by a doctor or apatient). For instance, motion sensor component 460 may determine apattern associated with a signal from a motion sensor device. Based onthis pattern, the motion sensory component 460 may differentiate betweenstimulus induced motion and other motions. In another aspect, the motionsensory component 460 may distinguish between motions based in part on atiming associated with stimulation component 410. In an example, motionsensor component 460 may monitor motion only during stimulation eventsor times near stimulation events. For instance, system 400 maysynchronize stimulation and response measurements, may determine timecorrelations, or the like.

FIGS. 5 and 6 depict multi-channel diagnostic systems 500 and 600 asdescribed herein. Diagnostic systems 500 and 600 may be used to diagnoseone or more compartments (and/or patients) and in particular to indicatewhether the one or more compartments has compartment syndrome and theseverity of the compartment pressure. While diagnostic systems 500 and600 are shown as dual channel systems, it is noted that diagnosticsystems 500 and 600 may comprise a different number of channels. It isfurther noted that diagnostic systems 500 and 600 may comprise othersystems, such as systems 100, 200, etc. For instance, diagnostic system100 may be operatively attached with various numbers of leads, types ofsensors, or the like.

Diagnostic system 500 may include a body 510 comprising variouscomponents (e.g., power source, memory, processor, etc.) and circuitry.The body 510 may be connected (removably or irremovably) to astimulation interface 530 comprising a signal path (e.g., wire, etc.)536 coupled (removably or irremovably) to a probe 532 and a pressuresensor 534. Further, stimulation interface 530 may comprise signal path(e.g., wire, etc.) 566 coupled (removably or irremovably) to a probe 562and a pressure sensor 564.

Diagnostic system 600 may include a body 610 comprising variouscomponents (e.g., power source, memory, processor, etc.) and circuitry.The body 610 may be connected (removably or irremovably) to astimulation interface 630 comprising a signal path (e.g., wire, etc.)636 coupled (removably or irremovably) to a probe 632. Further,stimulation interface 630 may comprise signal path (e.g., wire, etc.)666 coupled (removably or irremovably) to a probe 662.

Each signal path of systems 500 and 600 may represent a distinctchannel. It is noted that, while diagnostic system 500 is depicted tocomprise channels having both probes and pressure sensors, it is notedthat the channels may comprise different components. For example, singlepath 536 may not include pressure sensor 534. Similarly, diagnosticsystem 600 may include channels that comprise different components(e.g., single path 666 may include a pressure sensor).

In another example, a doctor may insert probe 532 into a patient tomonitor a first compartment of (e.g., a compartment of a left leg) andmay attach pressure sensor 534 to the first compartment of the patient.The first compartment may be a compartment suspected of compartmentsyndrome. The doctor may then insert probe 562 into the patient tomonitor a second compartment of (e.g., a compartment of a right leg) andmay attach pressure sensor 564 to the patient for monitoring pressure ofthe second compartment. The second compartment may be a compartment thatis healthy or not suspected of compartment syndrome. In someembodiments, the second compartment may be a contralateral muscle of thefirst muscle (e.g., mirror muscle on the opposite leg). In such anexample, a baseline may be established for the patient.

In embodiments, each channel may be attached to different users ordifferent compartments. For instance, a doctor may insert probe 532 intoa first patient and may attach pressure sensor 534 to the first patient.The doctor may also insert probe 562 into a second patient and mayattach pressure sensor 564 to the second patient. Such can allow formonitoring of multiple patients with only one device.

It is noted that systems 500 and 600 may determine whether the channelsare utilized for a single compartment/patient or for a plurality ofcompartments/patients. The number of compartments/patients may bedetermined based on received user input (e.g., input from a doctor),such as through controls, switches, knobs, etc. Based on thisdetermination, systems 500 and 600 may determine whether to setbaselines and how to control displays 524 and/or 624. For example, ifmultiple patients are being monitored or diagnosed, the display mayprovide two charts pertaining to each channel. If a single patient isbeing monitored, the display may provide a single chart for theconcerned compartment. As depicted in FIG. 5 , the display 524 mayprovide a chart for pressure of each channel, and may provide a chartfor stimulation thresholds of each channel. It is noted that display524/624 may be configured to render various other outputs based onwhether a single patient is monitored or whether multiple patients aremonitored. For instance, the display may render an adjusted stimulusparameter and the parameter may be plotted as the stimulus currentamplitude with a fixed pulse duration, the stimulus pulse duration at afixed current amplitude, or the charge of the stimulus pulse. It isnoted that a plot may be over a specific period of time, may representthe complete history of stimulation/pressure, or the like.

In another aspect, the systems 500 and 600 may be designed for aspecific use and may not determine whether the channels are utilized fora single patient or for a plurality of patients.

FIGS. 7 and 8 depict percutaneous needle systems 700 and 800, which maystimulate a compartment via percutaneous needles 710 and 810. Needles710 and 810 may be connected to a body 730/830 via leads 720/820. It isnoted that various systems may utilize percutaneous needles 710 and 810.Further, system 800 is depicted as including return electrode 802.

As described herein, various systems and methods may provide objectiveevidence of muscle viability and contractility and would allow detectionof a trend toward diminution of muscle excitability, indicative ofischemia, over time. The device may sound an audible alarm or display avisual indicator when the threshold is increased to a predeterminedlevel indicating risk of tissue damage. Unlike compartment pressuremeasurements, this would be a direct measurement of muscle function,which is the primary issue of concern with compartment syndrome.

The method for detecting compartment syndrome may include identifying apatient with an injury that may result in compartment syndrome.According to the method, the patient may be screened for symptomsassociated with compartment syndrome, including, but not limited to painout of proportion to the injury, paresthesias (numbness), paralysis(loss of contractility), pallor (loss of pulses), poikilothermia, skintenseness, and vascular congestion. If, based on type of injury, thepresentation of symptoms or both, it is believed that compartmentsyndrome may result, the patient can be monitored to determine thelikelihood of compartment syndrome developing.

Monitoring may include measuring the compartment pressure in theaffected muscle. Pressure may be measured by any appropriate means formeasuring compartment pressure. For example, pressure may be measured bya needle and a manometer or pressure transducer.

If the measured pressure is greater than 35 mm Hg or within 20 mm Hg ofdiastolic pressure, the risk of developing compartment syndrome may besignificant and fasciotomy may be warranted.

If the measured pressure is less than 35 mm Hg and greater than about 20mm Hg, or if the patient is exhibiting symptoms that indicate thepossibility that compartment syndrome might develop, the patient can bemonitored using a simulation device. Alternatively, a patient may bemonitored with a stimulation device without first measuring thecompartment pressure.

The method for determining the risk of developing compartment syndromeincludes assessing common factors associated with compartment syndrome.Factors to be considered when assessing the risk of developingcompartment syndrome may include the timeline of changes (e.g., muscleresponses, ischemia, biological substances, irreversible damage, etc.)associated with compartment syndrome. The timeline of changes in muscleresponse in relationship to progression of ischemia may provide insightinto when muscle activation is lost relative to when irreversible damageoccurs. For example, if muscle contraction is lost quickly (within 1hour) and irreversible damage does not begin until later (5 hours),there may be a sufficient window (e.g., 4 hours) in which a fasciotomycan be performed to prevent damage. However, if muscle contractionslowly fades over several hours and irreversible damage is occurring inparallel, then the muscle response may not provide a warning soon enoughto prevent damage.

The effects of compartment syndrome are time dependent. If, after thefasciotomy is performed, the muscle appears to bulge out of theincision, then it is likely that the fasciotomy was needed. If, on theother hand, the muscle appears healthy, it is possible that thefasciotomy was not necessary or that the fasciotomy was performed earlyenough to prevent ischemia and interstitial edema.

In view of the subject matter described herein, methods that may berelated to various embodiments may be better appreciated with referenceto the flowcharts of FIGS. 9-11 . While the methods are shown anddescribed as a series of blocks, it is noted that associated methods orprocesses are not limited by the order of the blocks. It is furthernoted that some blocks and corresponding actions may occur in differentorders or concurrently with other blocks. Moreover, different blocks oractions may be utilized to implement the methods described hereinafter.Various actions may be completed by one or more of users, mechanicalmachines, automated assembly machines (e.g., including one or moreprocessors or computing devices), or the like.

FIG. 9 depicts an exemplary flowchart of non-limiting method 900associated with a diagnosis system, according to various aspects of thesubject disclosure. As an example, method 900 may determine astimulation threshold associated with a motor unit.

At 902, a doctor may position electrode(s) based on a tissue regionidentified for stimulation. The tissue region may be a region selectedfor stimulation (e.g., through muscle or neural tissue) of motor unitswithin a compartment. As described herein, the compartment may be acompartment at risk of compartment syndrome or a contralateralcompartment.

At 904, a system may provide a stimulation signal to the tissue regionidentified for stimulation. At 906, the system or a doctor may observethe response to stimulation. The response may be actuation of a motorunit or no actuation of a motor unit. At 908, a system or a doctor mayadjust stimulation parameters based at least in part on the responseobserved at 906. It is noted that the stimulation, observation, andadjustment may be iterated one or more times. For example, the iterationmay continue until a stimulation threshold is determined at 910, such asby a system or a doctor.

FIG. 10 depicts an exemplary flowchart of non-limiting method 1000associated with a diagnosis system, according to various aspects of thesubject disclosure. As an example, method 1000 may determine astimulation threshold associated with a motor unit.

At 1002, a doctor or a system may monitor stimulation parameters. In anaspect, the stimulation parameters may be stored in a memory. At 1004, adoctor or a system may monitor compartment pressure. It is noted thatthe compartment pressure may be stored in memory. It is noted that someor all of the stimulation and/or pressure parameters may be stored inmemory. For instance, system 100 or another system may monitor theparameters over a certain time period (e.g., over the past hour, 30minutes, etc.).

At 1006, a doctor or a system may determine trends in history associatedwith compartment pressure and stimulation, as described herein. Thetrends may indicate changes in pressure/stimulation parameters, rates ofchange, or the like.

At 1008, a system may generate alarms as described herein. The alarmsmay be audible alarms, visual alarms, tactile alarms, or the like. Forexample, the system may generate alarms based on the trends, such as analarm based on a change in pressure/stimulation parameters exceeding athreshold rate of change, pressure/stimulation parameters exceeding athreshold level, or the like.

Example

An 11-year-old girl sustained a type III supracondylar elbow fracture.The patient underwent closed reduction and internal fixation of thefracture. However, postoperatively she complained of severe andunremitting pain in the arm. The pain was so severe that readmission tothe hospital for pain control was necessary and compartment syndrome wasconsidered. Compartment pressures were measured in the dorsal and volarcompartments. The pressure was found to be in the range from the highteens to the mid twenties.

The clinical observation of severe pain and the ambiguous pressurereadings indicated that the patient might be a risk for developingcompartment syndrome.

Muscle contractility was measured directly using a stimulator, such as aCHECKPOINT stimulator. Placing the ground in the subcutaneous tissues,an insulated anesthesia block needle was connected to the stimulator andinserted percutaneously in the superficial and deep compartments.

Good stimulation, as evidenced by strong finger flexion, could beelicited in the 2 mA range. Stimulation in the low 20 mA range produceda vigorous, tetanic contraction of the flexor muscles, indicating muscleviability and normal function. The stimulator was next used to definethe threshold at which stimulation first occurred by graduallyincreasing the stimulus intensity and noting the point at which fingermotion was first observed.

The finding of normal muscle excitability suggested that a subcutaneousfasciotomy with a 1 cm incision, placed in an inconspicuous location,rather than a standard fasciotomy through a long elbow-to-wrist incisionwould be a proper course of treatment.

Post-operatively, the patient's pain resolved and at the next follow-upoffice visit one week after the surgery, the patient had full fingermotion, no pain and normal motor and sensory function.

Thus, a percutaneous stimulator was used to directly test and assessmuscle viability and excitability in a patient at risk for developingcompartment syndrome with ambiguous physical findings and pressuremeasurements. Without the stimulator, a full fasciotomy would have beennecessary to avoid the risk of missing a compartment syndrome. Such atechnique might help avoid unnecessary fasciotomies, with the attendantscarring and risks associated with multiple surgical procedures.

Although the embodiments of the present invention have been illustratedin the accompanying drawings and described in the foregoing detaileddescription, it is to be understood that the present invention is not tobe limited to just the embodiments disclosed, but that the inventiondescribed herein is capable of numerous rearrangements, modificationsand substitutions without departing from the scope of the claimshereafter. The claims as follows are intended to include allmodifications and alterations insofar as they come within the scope ofthe claims or the equivalent thereof.

What has been described above may be further understood with referenceto the following figures. FIGS. 11 and 12 provide exemplary operatingenvironments or systems capable of implementing one or more systems,apparatuses, or processes described above. FIGS. 11 and 12 are notintended to limit the scope of such systems, apparatuses, or processes.By way of example, computing environment 1100 may refer to one or moreembodiment of the various embodiments described with reference to theabove figures. However, variations to computing environment 1100 may beobvious to achieve aspects or processes described herein.

FIG. 11 is a schematic diagram of a computing environment 1100 inaccordance with various disclosed aspects. It is noted that environment1100 may include various other components or aspects. As depicted,system 1100 may include one or more client(s) 1102 (e.g., stimulationdevice and/or a device connected to the stimulation device), one or moreserver(s) 1104, one or more client data store(s) 1120, one or moreserver data store(s) 1110, and a communication framework 1106.

While depicted as a desktop computer(s), client(s) 1102 may includevarious other devices that may comprise hardware and/or software (e.g.,program threads, processes, computer processors, non-transitory memorydevices, etc.). In an example, client(s) 1102 may include laptopcomputers, smart phones, tablet computers, diagnostic devices, pressuresensors, stimulation device, medical devices, etc. The client(s) 1102may include or employ various aspects disclosed herein. For example,client(s) 1102 may include or employ all or part of various systems(100, 200, 300, etc.) and processes (e.g., method 900, 1000, etc.)disclosed herein. In an embodiment, client(s) 1102 may include astimulation device having a communication component configured forcommunicating via communication framework 1106. It is noted that thecommunication component may include wireless or wired communicationscapabilities as described herein.

Likewise, server(s) 1104 may include various devices that may comprisehardware and/or software (e.g., program threads, processes, computerprocessors, non-transitory memory devices, etc.). Server(s) 1104 mayinclude or employ various aspects disclosed herein. For example,server(s) 1104 may include or employ all or part of various systems(100, 200, 300, etc.) and processes (e.g., method 900, 1000, etc.)disclosed herein. It is noted that server(s) 1104 and client(s) 1102 maycommunicate via communication framework 1106. In an exemplarycommunication, client(s) 1102 and server(s) 1104 may utilize packeteddata (e.g., data packets) adapted to be transmitted between two or morecomputers. For instance, data packets may include coded informationassociated with a stimulation process, diagnostic process,pressure-monitoring process, or the likes.

Communication framework 1106 may comprise various network devices (e.g.,access points, routers, base stations, etc.) that may facilitatecommunication between client(s) 1102 and server(s) 1104. It is notedvarious forms of communications may be utilized, such as wired (e.g.,optical fiber, twisted copper wire, etc.) and/or wireless (e.g.,cellular, Wi-Fi, near field communication, etc.) communications.

In various embodiments, client(s) 1102 and server(s) 1104 mayrespectively include or communicate with one or more client datastore(s) 1120 or one or more server data store(s) 1110. The data storesmay store data local to client(s) 1102 or server(s) 1104.

In at least one embodiment, a client of client(s) 1102 may transfer datadescribing a stimulus parameter, a user response to stimulation, a timeof stimulation, or the likes to a server of server(s) 1104. The servermay store the data and/or employ processes to alter the data. Forexample, the server may transmit the data to other clients of client(s)1102, such as a physician's or facility's desktop computer.

FIG. 12 is a block diagram of a computer system 1200 that may beemployed to execute various disclosed embodiments. It is noted thatvarious components may be implemented in combination with computerexecutable instructions, hardware devices, and/or combinations ofhardware and software devices that may be performed by computer system1200.

Computer system 1200 may include various components, hardware devices,software, software in execution, and the likes. In embodiments, computersystem 1200 may include computer 1200. Computer 1200 may include asystem bus 1208 that couples various system components. Such componentsmay include a processing unit(s) 1204, system memory device(s) 1206,disk storage device(s) 1214, sensor(s) 1235, output adapter(s) 1234,interface port(s) 1230, and communication connection(s) 1244. One ormore of the various components may be employed to perform aspects orembodiments disclosed herein.

Processing unit(s) 1204 may comprise various hardware processingdevices, such as single core or multi-core processing devices. Moreover,processing unit(s) 1204 may refer to a “processor,” “controller,”“computing processing unit (CPU),” or the likes. Such terms generallyrelate to a hardware device. Additionally, processing unit(s) 1204 mayinclude an integrated circuit, an application specific integratedcircuit (ASIC), a digital signal processor (DSP), a field programmablegate array (FPGA), a programmable logic controller (PLC), a complexprogrammable logic device (CPLD), a discrete gate or transistor logic,discrete hardware components, or the likes.

System memory 1206 may include one or more types of memory, suchvolatile memory 1210 (e.g., random access memory (RAM)) and non-volatilememory 1212 (e.g., read-only memory (ROM)). ROM may include erasableprogrammable ROM (EPROM), electrically erasable programmable ROM(EEPROM). In various embodiments, processing unit(s) 1204 may executecomputer executable instructions stored in system memory 1206, such asoperating system instructions and the likes.

Computer 1202 may also be one or more hard drive(s) 1214 (e.g., EIDE,SATA). While hard drive(s) 1214 are depicted as internal to computer1202, it is noted that hard drive(s) 1214 may be external and/or coupledto computer 1202 via remote connections. Moreover, input port(s) 1230may include interfaces for coupling to input device(s) 1228, such asdisk drives. Disk drives may include components configured to receive,read and/or write to various types of memory devices, such as magneticdisks, optical disks (e.g., compact disks and/or other optical media),flash memory, zip drives, magnetic tapes, and the likes.

It is noted that hard drive(s) 1214 and/or other disk drives (ornon-transitory memory devices in general) may store data and/orcomputer-executable instructions according to various describedembodiments. Such memory devices may also include computer-executableinstructions associated with various other programs or modules. Forinstance, hard drives(s) 1214 may include operating system modules,application program modules, and the likes. Moreover, aspects disclosedherein are not limited to a particular operating system, such as acommercially available operating system.

Input device(s) 1228 may also include various user interface devices orother input devices, such as sensors (e.g., microphones, pressuresensors, light sensors, etc.), scales, cameras, scanners, facsimilemachines, and the likes. A user interface device may generateinstructions associated with user commands. Such instructions may bereceived by computer 1202. Examples of such interface devices include akeyboard, mouse (e.g., pointing device), joystick, remote controller,gaming controller, touch screen, stylus, and the likes. Input port(s)1230 may provide connections for the input device(s) 1228, such as viauniversal serial ports USB ports), infrared (IR) sensors, serial ports,parallel ports, wireless connections, specialized ports, and the likes.

Output adapter(s) 1234 may include various devices and/or programs thatinterface with output device(s) 1236. Such output device(s) 1236 mayinclude LEDs, computer monitors, touch screens, televisions, projectors,audio devices, printing devices, or the likes.

In embodiments, computer 1202 may be utilized as a client and/or aserver device. As such, computer 1202 may include communicationconnection(s) 1244 for connecting to a communication framework 1242).Communication connection(s) 1244 may include devices or componentscapable of connecting to a network. For instance, communicationconnection(s) 1244 may include cellular antennas, wireless antennas,wired connections, and the likes. Such communication connection(s) 1244may connect to networks via communication framework 1242. The networksmay include wide area networks, local area networks, facility orenterprise wide networks (e.g., intranet), global networks (e.g.,Internet), satellite networks, and the likes. Some examples of wirelessnetworks include Wi-Fi, Wi-Fi direct, BLUETOOTH™, Zigbee, and other802.XX wireless technologies. It is noted that communication framework1242 may include multiple networks connected together. For instance, aWi-Fi network may be connected to a wired Ethernet network.

The terms “component,” “module,” “system,” “interface,” “platform,”“service,” “framework,” “connector,” “controller,” or the like aregenerally intended to refer to a computer-related entity. Such terms mayrefer to at least one of hardware, software, or software in execution.For example, a component may include a computer-process running on aprocessor, a processor, a device, a process, a computer thread, or thelikes. In another aspect, such terms may include both an applicationrunning on a processor and a processor. Moreover, such terms may belocalized to one computer and/or may be distributed across multiplecomputers.

What has been described above includes examples of the presentspecification. It is, of course, not possible to describe everyconceivable combination of components or methodologies for purposes ofdescribing the present specification, but it is noted that many furthercombinations and permutations of the present specification are possible.Each of the components described above may be combined or added togetherin any permutation to define a stimulation device or method.Accordingly, the present specification is intended to embrace all suchalterations, modifications and variations that fall within the spiritand scope of the appended claims. Furthermore, to the extent that theterm “includes” is used in either the detailed description or theclaims, such term is intended to be inclusive in a manner similar to theterm “comprising” as “comprising” is interpreted when employed as atransitional word in a claim.

Although the embodiments of the present invention have been illustratedin the accompanying drawings and described in the foregoing detaileddescription, it is to be understood that the present invention is not tobe limited to just the embodiments disclosed, but that the inventiondescribed herein is capable of numerous rearrangements, modificationsand substitutions without departing from the scope of the claimshereafter. The claims as follows are intended to include allmodifications and alterations insofar as they come within the scope ofthe claims or the equivalent thereof.

1.-17. (canceled)
 18. A compartment syndrome diagnosis device,comprising: a probe comprising an electrode; and an electricalstimulation device, wherein electrical stimulation device generates astimulus signal intended to elicit a visible and/or palpable musclecontraction of a motor unit of a compartment and the electricalstimulation device monitors at least one stimulation parameterassociated with a stimulation threshold of the motor unit of thecompartment, wherein the electrical stimulation device operativelydelivers, based on the stimulation parameter, a stimulation signal tothe motor unit via the electrode.
 19. The device of claim 18, whereinthe probe is configured to be at least partially implanted into a tissueregion.
 20. The device of claim 18, wherein the electrode is configuredto deliver unipolar stimulation to the motor unit.
 21. The device ofclaim 18 further comprising at least one control device configured toreceive an input related to the stimulation signal.
 22. The device ofclaim 21, wherein the at least one control device comprises at least oneof a user input device, a muscle twitch sensor operatively coupled to apatient receiving the electrical stimulation, or an electromyographelectrode comprising at least one of a surface electrode or apercutaneous lead.
 23. The device of claim 22, wherein the at least onecontrol device generates a notification indicative of at least one of aprompt to a user to initiate iterating alteration of the stimulussignal, upon the at least one stimulation parameter exceeding athreshold, a rate of alteration of the at least one stimulationparameter exceeding a threshold rate, or a weighted combination thereof.24. The device of claim 23, wherein the at least one control devicegenerates notification as at least one of an audible notification,visual notification, a tactile notification, or a communicationnotification sent through a communications network to a user device. 25.The device of claim 18, wherein the stimulation parameter forstimulation of the motor unit comprises a stimulation signal comprisingwithin a range of frequency, wherein the range is greater than about 0.7to less than about 3 hertz.
 26. The device of claim 18, furthercomprising a pressure sensor configured to measure interstitial pressurewithin the compartment.
 27. A compartment syndrome diagnosis device,comprising: a stimulation device that generates a stimulation signal; aprobe operatively in communication with a motor unit, wherein thestimulation device stimulates the motor unit via the probe, wherein thestimulation signal comprises parameters intended to elicit a palpableand/or visible muscle contraction of the motor unit; and a sensorconfigured to measure a pressure of a compartment comprising the motorunit.
 28. The device of claim 27 further comprising a display deviceindicating stimulation parameters associated with stimulation andpressure parameters.
 29. The device of claim 28 further comprising amemory operatively storing a history of the stimulation parameters. 30.The device of claim 29, wherein the sensor comprises an intermuscularpressure sensing component.
 31. The device of claim 27 furthercomprising a motion sensor operatively measuring the palpable and/orvisible muscle contraction.
 32. A compartment syndrome diagnosis device,comprising: a stimulation component configured to generate a stimulationsignal; a probe operatively in communication with a motor unit, whereinthe stimulation component is configured to stimulate the motor unit viathe probe and based on the stimulation signal, wherein the stimulationsignal comprises parameters intended to elicit a palpable and/or visiblemuscle contraction of the motor unit; an intermuscular pressure sensingcomponent configured to measure a pressure of a compartment comprisingthe motor unit; a display device configured to render a displayindicating stimulation parameters associated with stimulation andpressure parameters; and a memory operatively storing a history of thestimulation parameters.
 33. The device of claim 32, wherein the probe isconfigured to be at least partially implanted into the tissue region.34. The device of claim 32, wherein the probe comprises at least one ofa needle, a catheter, or an intramuscular lead.
 35. The device of claim32, wherein the probe comprises an electrode configured for deliveringunipolar stimulation to the motor unit.
 36. The device of claim 35further comprising a return electrode coupled to the stimulationcomponent, the return electrode configured to provide a return path forthe stimulation signal.
 37. The device of claim 32, wherein thestimulation signal comprises a frequency that is greater than about 0.5to less than about 50 Hertz.
 38. The device of claim 32, furthercomprising: a printer configured to print information associated withthe stimulation signal, wherein the printer comprises at least one of anintegrated printer that is integrated within the stimulation componentor an external printer that is wirelessly connected or hard-wiredconnected to the stimulation component.
 39. The device of claim 32,wherein the stimulation component is a wearable device.
 40. The deviceof claim 32, further comprising a motion sensor operatively measuringthe palpable and/or visible muscle contraction.